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DeRoyal Cientifica De Latinoamerica S.R.L. FDA Record

Warning letters, Form 483s, inspections, recalls and 510(k) clearances

DeRoyal Cientifica De Latinoamerica S.R.L. has 0 FDA recalls, 2 inspections, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to DeRoyal Cientifica De Latinoamerica S.R.L., the most recent on Aug 12, 2013.

What these totals cover: FDA records filed under the name "DeRoyal Cientifica De Latinoamerica S.R.L." and its spelling variant "Deroyal Cientifica De Latinoamerica".

Latest inspection: Oct 2, 2014 · VAI

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Summary

Record counts and when each FDA source was last refreshed
Records	Count	Last refreshed	Source as of	Status
Recalls	0	Nov 8, 2026	File dated Nov 3, 2026	Current
510(k) clearances	0	Nov 8, 2026	File dated Nov 2, 2026	Current
Inspections	2	Nov 14, 2026	Newest record Nov 5, 2026	Current
Compliance actions	1	Nov 2, 2026	Newest record Oct 29, 2026	Current

DeRoyal Cientifica De Latinoamerica S.R.L. FDA Warning Letters

1 warning letter on Aug 12, 2013.

Issued	Subject	Issuing office	Close-out letter
Aug 12, 2013

A warning letter is FDA's formal notice that a company has violated FDA requirements. Each date links to the letter on fda.gov where FDA has it online. Search the text of every letter with the FDA warning letter search.

Recent FDA inspections

2 inspections from Feb 28, 2013 to Oct 2, 2014.

Date	Site	Product	Classification	FEI
Oct 2, 2014	Heredia, Costa Rica	Devices	Voluntary Action Indicated (VAI)	3006469671
Feb 28, 2013	Heredia, Costa Rica	Devices	Official Action Indicated (OAI)	3006469671

NAI: No objectionable conditions or practices were found during the inspection.
VAI: Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
OAI: Regulatory and/or administrative actions are recommended.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

Compliance Actions

FDA's compliance actions data lists 1 compliance action under DeRoyal Cientifica De Latinoamerica S.R.L.: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Aug 12, 2013.

The warning letters in this data are listed above, together with the letters FDA posts online; a letter found in both is shown once. Other actions are not listed on this page. Search them with the FDA warning letter search or browse all compliance actions.

FDA-inspected facilities

1 inspected site, newest inspection first.

Facility	Location	Inspections	Latest
FEI 3006469671	Heredia, Costa Rica	2	Oct 2, 2014

DeRoyal Cientifica De Latinoamerica S.R.L. and the FDA: common questions

Has DeRoyal Cientifica De Latinoamerica S.R.L. received an FDA warning letter?

Yes. FDA has issued 1 warning letter to DeRoyal Cientifica De Latinoamerica S.R.L.. The most recent is dated Aug 12, 2013.

Has DeRoyal Cientifica De Latinoamerica S.R.L. received an FDA Form 483?

FDA has not published a Form 483 for "DeRoyal Cientifica De Latinoamerica S.R.L." in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect DeRoyal Cientifica De Latinoamerica S.R.L.?

The most recent FDA inspection on file ended Oct 2, 2014 at Heredia, Costa Rica and was classified VAI. FDA has 2 inspections of DeRoyal Cientifica De Latinoamerica S.R.L. on file, 1 of them classified OAI (official action indicated).

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